Useful Advices - Business

You need to begin to get the measure of people early on. Beware of thinking you are an expert psychologist, but do:

• Listen to what people say and how they say it

• Read between the lines

• Check immediately anything that is unclear

• Address

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

(or note) any apparent hidden agendas

• Be aware of the informal communications channels as well as the hierarchical ones

• Note any areas requiring further investigation

You need to get to know people, their working methods, strengths and wea

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

knesses. This cannot be done in five minutes; start early and handle it objectively.

Beware of making, and acting on unwarranted, instant assumptions about people.

A First Staff Meeting:

Get the team together as soon as possible,

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

on the first day if you can. Remember, your meetings speak volumes about the kind of manager you are. Plan to make them really effective, therefore.

• Set the time and date to be as convenient to people as possible (you may need to check this wit

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

h a new group)

• Organise the administration (place, refreshments, acting to stop interruptions, etc)

• Issue a clear agenda in advance

• Make sure the agenda is worthwhile, fits the time available and is useful for those attending

• Tell peop

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

le what you expect from them (for instance, if someone is to give you a run down on their section or work, let them plan how to do it from your clear brief)

• Set start and finish times – and try to stick to them (you are setting up habits here s

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

o be sure to start on time)

• Give people a say – listen – make notes and be seen to take an interest in their views

• Make any action points clear (whether for the group or for individuals)

• Link to the next meeting (you might set a date)

•

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

onfirm anything necessary in writing

A meeting should motivate. People will wonder how your presence and style will affect them. Show them your impact will be beneficial. Spell out how.

The agenda for the first meeting will depend on your

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

precise role. It is likely to include items such as:

• Your understanding of the team’s role and immediate goals

• Any necessary explanations for change (e.g. why you are now manager)

• The current position (progress, problems, opportunities)

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

• A chance to ask questions

• Details of, and reasons for, any immediate changes

• Reporting and communications procedures (e.g.: when and how you plan to keep in touch with individuals and the group)

• Action points on immediate operational i

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ssues

You should ask as much as inform, and not change existing procedures without good reasons (and knowing the facts). However logical changes may be, people will be suspicious (Will it adversely affect me?) so see, and explain things,

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

from their point of view. Empathy is your greatest ally in the early stages of managing a group.

Early Issue: Early Action

Here is something to do as soon as possible (though always with a firm basis of information). Identify an i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ssue waiting for attention and which is seen as needing attention. And sort it out.

Something where you can:

• Tell people you recognise it is a priority, one that must not be left

• Explain the basis of a decision

• Specify action to b

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e taken (this could be a temporary measure)

• Take any additional action necessary (e.g.: confirm in writing, consult or advise further a field than your section)

• Get it off the department’s to do list promptly and definitely

You need a task

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

hat is seen as due (overdue?) for action, one that will also be seen as well resolved – an example of how you mean to go on. Select carefully, act in a considered fashion and this will not only clear an outstanding issue but will also say somet

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

hing positive about you.

Ground Rules

Consultation is important to the management process but there are times when arguments must be avoided and an authoritative approach taken. If every initiative involved lengthy consultation, time

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

would run out, little would get done and we would all be in trouble.

You, might, for example, consult about departmental policy on dress code or what can be claimed on expenses. Then – for a while at least – what is decided (what you decide) assu

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

mes the status of a rule. It is expected that people toe the line, and no time is wasted on endless arguments about exceptions. In due course you may need to reassess the situation and possibly change the rules.

The same can be said of meetings <

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

i> (When we set the date for a staff meeting, we all stick to it and start on time) and procedures (When certain documents are sent out you get a copy – always) .

How you act in this kind of way affects your profile as a manager. If people

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

say of you: If you attend one of Jonathan’s meetings you’d better be on time, it is surely a good thing – as long as they believe you are a manager who understands their point of view.

Copyright © 2007 Jonathan Farrington. All rights reserve

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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